The program that keeps watch over the management of dangerous pathogens at research laboratories still isn’t up to snuff, according to a new report from the U.S. Government Accountability Office (GAO).
The Federal Select Agent Program, run jointly by the Centers for Disease Control and Prevention (CDC) and the Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS), regulates how government, academic, and industry labs store, use, and transfer 66 potentially harmful organisms and toxins, including anthrax and plague. It has faced new scrutiny from Congress and GAO in recent years after a string of safety incidents involving select agents at laboratories run by the federal government.
In 2014, as many as 84 CDC employees were exposed to live samples of anthrax bacteria that were inadvertently shipped between labs, leading the agency to temporary close two labs and halt shipment of pathogens. The same year, forgotten vials of smallpox virus were discovered on the campus of the National Institutes of Health. In response to these and other mishaps, the White House announced far-reaching measures in 2015 to improve biosafety procedures, including increased training for lab workers. Congress also asked GAO to evaluate federal agency procedures for managing risky pathogens.
The resulting report, released today, finds enduring problems with the Federal Select Agent Program’s organization and priorities. It says that the program is sometimes not sufficiently independent from the government laboratories it oversees, some of which are also based at CDC and USDA. The two agencies have made organizational changes to distance the program’s activities from sister offices that house regulated labs, and have agreed to conduct inspections of one another’s labs to avoid conflicts of interest. But the report notes that APHIS has conducted at least three inspections of labs owned or operated by USDA (its parent agency).
It also finds that lab inspections don’t focus on the highest-risk activities. For example, some experts consulted by GAO said that the program spent too much time on security measures, such as reviewing lab inventory methods and theft prevention efforts, and not enough time verifying that their laboratory procedures protect researchers and the public from accidental infections and other problems. (Failure to follow proper procedures to ensure anthrax samples were inactivated appeared to be the culprit in the 2014 CDC incident, the agency found in an internal report.)
The program’s inspectors, meanwhile, are often overworked and sometimes lack necessary technical expertise, the new report says, despite recent efforts to hire more staff and improve their training.
Among the report’s recommendations are that APHIS and CDC make a “plan to identify which laboratory activities carry the highest biological safety and security risks” and target those activities in future inspections.
GAO’s acting director for health care, Mary Denigan-Macauley, will discuss the findings at a hearing of the U.S. House of Representatives Energy and Commerce Committee’s oversight and investigations subcommittee on Thursday, alongside representatives of CDC and APHIS.